FDA 510(k) Applications Submitted by Brian Smekal
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K130120 |
01/17/2013 |
EXTREMITY MEDICAL IP FUSION SYSTEM |
EXTREMITY MEDICAL, LLC |
| K150166 |
01/26/2015 |
Extremity Medical Suture Anchor |
EXTREMITY MEDICAL LLC |
| K160191 |
01/27/2016 |
Align Anterior Ankle Fusion Plate |
Extremity Medical, LLC |
| K150309 |
02/09/2015 |
Extremity Medical Calcaneal Osteotomy Device |
EXTREMITY MEDICAL, LLC |
| K180808 |
03/28/2018 |
Omni Foot Plating System |
Extremity Medical, LLC |
| K171018 |
04/05/2017 |
Axis Charcot Fixation System, 4.5 to 8.5mm Screw System |
Extremity Medical, LLC. |
| K181067 |
04/23/2018 |
AlignX Ankle Fusion System |
Extremity Medical, LLC |
| K191525 |
06/10/2019 |
KinematX Total Wrist Arthroplasty System |
Extremity Medical, LLC. |
| K212297 |
07/22/2021 |
Omni Foot and Ankle Plating System |
Extremity Medical, LLC. |
| K172260 |
07/27/2017 |
Omni Foot Plating System |
Extremity Medical, LLC. |
| K192592 |
09/20/2019 |
Axis Plating System |
Extremity Medical, LLC. |
| K152710 |
09/21/2015 |
HammerFiX Device |
EXTREMITY MEDICAL, LLC |
| K062876 |
09/26/2006 |
PRIMACONNEX CERAMIC ABUTMENTS |
LIFECORE BIOMEDICAL, INC. |
| K133636 |
11/26/2013 |
EXTREMITY MEDICAL HAMMERTOE DEVICE |
EXTREMITY MEDICAL, LLC. |
| K143402 |
11/28/2014 |
Extremity Medical Calcaneal Osteotomy Device |
EXTREMITY MEDICAL LLC |
| K053643 |
12/30/2005 |
STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 |
LIFECORE BIOMEDICAL, INC. |
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